Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mask, Surgical
510(k) Number K925185
Device Name ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS
Applicant
Louis M. Gerson Co., Inc.
Middleboro,  MA  02346
Applicant Contact WILLIE YUNG
Correspondent
Louis M. Gerson Co., Inc.
Middleboro,  MA  02346
Correspondent Contact WILLIE YUNG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/14/1992
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-